Company: Nexstim PLC
Date of Enforcement Report 6/14/2017
Class lI:
PRODUCT
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus.
Recall Number Z-2320-2017
REASON
Software defect: the NBS software may accidentally generate duplicate copies of one or several files..
RECALLING FIRM/MANUFACTURER
Nexstim PLC, Helsinki, Finland on 3/14/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
21
DISTRIBUTION
Worldwide Distribution – US to GA only, Foreign: Europe.
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